FierceBiotech and FiercePharma Jobs
Bioassay Associate - Randstad
Categories: Biotherapeutic
Position Description
Job Responsibilities:
• Participate in developing and optimization of new procedures for characterizing protein and viral intermediates and vaccine candidates to enhance understanding of their biological functions and properties.
• Prepare Technical Reports and Standard Operating Procedures in support of bioassay validation in Quality Control groups.
• Execute assay qualification and tech transfer to external or internal Quality Control groups, provide trouble-shooting assistance if needed.
• Perform testing in support of Process and Formulation Development function in the company.
• Conduct stability testing for biological properties of the products for various projects.
• Manage computer and sample databases, maintain lab notebooks and other required documentation associated with assay development and stability testing.
• Manage the maintenance and calibration of Instruments and Equipment in development laboratory.
• Maintain an appropriate level of familiarity with the scientific literature and new technology in order to contribute maximally to company’s development efforts. Attend training and seminars, both on- and offsite to further this contribution.
• Actively participate in group and project team meetings, contributing technical expertise as needed.
• Perform other duties as assigned.
Qualifications:
The right individual needs a BS/MS degree in a related scientific discipline with a minimum of 8 years of hands-on experience in GXP environment in Assay Development, Assay Validation or Quality Control with an understanding of regulatory compliance requirement. Individual should exercise independent judgment in development of new methods, techniques and evaluation criteria. Demonstrated strong verbal and written communication skills are a plus.
Work location: Cambridge, MA




